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Status unknownNCT03153306Updated May 15, 2017

Importance of the Infusion Rate for the Plasma Expanding Effect of 5% Albumin in the Septic Patient

A Phase 4 interventional study of albumin in Sepsis, sponsored by Hainan People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-15.

Sponsored by Hainan People's Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Correction of hypovolemia is an important therapeutic measure，Even though there is no consensus regarding infusion rates, a plasma volume (PV) expander is often given at a fast rate to treat a suspected hypovolemia without delay which can be associated with aggravation of adverse interstitial accumulation of macromolecules and fluid, especially in inflammatory conditions such as sepsis.the smallest possible volumes for PV resuscitation to maintain normovolemia should be used to reduce the risk of simultaneous interstitial fluid accumulation. The investigators tested the hypothesis that a slow infusion rate of a PV expander results in better plasma expansion than a fast infusion rate to patients with severe sepsis or septic shock.

02

Conditions studied

  • Sepsis

Keywords

  • Albumin
03

In context

Lead sponsor

Hainan People's Hospital is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • admitted to the ICU patients with severe sepsis or septic shock (diagnosis according to the 2012 surviving sepsis campaign guidelines)
  • there is low blood pressure (SBP \< 90 or mean arterial pressure(MAP) \< 65 or the systolic blood pressure is decreased 40 mmHg more than the basic level) or lactic acid or greater for 4 mmol/l
  • the informed consent

Exclusion criteria

Exclusion Criteria:

  • less than 18 years of age
  • more than 80 years old
  • pregnant women
  • albumin allergies
  • the dying patients expected lifetime no more than 24 hours)
  • patient with myocardial infarction, heart failure
  • liver failure
  • refused to sign the informed consent
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    the "bolus" group

    10ml/kg of the natural colloid 5% albumin was given at 1 hrs.

    Drug: albumin

  • Experimental
    the"continuous" group

    10ml/kg of the natural colloid 5% albumin was given over 6 hrs

    Drug: albumin

Interventions

  • Drugalbumin

    Two groups were formed at random for each fluid. In one group, 10ml/kg of 5% albumin was given over 1 hour (the "bolus" group), and in the other group, the same volume was given over 6 hrs (the"continuous" group)

    Also known as: human albumin(Austria)

06

What researchers measure

Primary outcomes

  1. Extravascular lung water (EVLW) before and after fluid resuscitation

    Extravascular lung water （EVLW）is measured by Pulse index continous cardiac output (PICCO) before and after fluid resuscitation in each group

    Time frame: 6 hour

07

Study locations

1 of 1 sites recruiting
  • Hainan Provincial People'S Hospital
    Haikou, Hainan 570000, China
    • rui li, PhD Candidate · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03153306
Lead sponsor
Hainan People's Hospital
Collaborators
Southern Medical University, China
Responsible party
rui li (Attending Doctor, critical care medicine department, Hainan People's Hospital) — Principal investigator
First posted
May 15, 2017
Start date
Jun 2016
Primary completion
Dec 2017 (estimated)
Completion
Mar 2018 (estimated)
Last update
May 15, 2017

Study contacts

rui li, PhD Candidate
Contact
liruixxmc@163.com
18289559251 ext. +86

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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